Skip to main content
OpenTrials
Completed

NCT Number: NCT04093180

Intensive Neurorehabilitation for Cerebral Palsy

Evaluation of effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a single-blinded randomized controlled trial with two groups.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

About this study

Intensive Neurophysiologic Rehabilitation System (INRS) is an intensive multimodal rehabilitation system, whereby versatile and multi-faceted methods are combined with the aim of improvement of functioning and quality of life of children with CP. Treatment components are addressing different functional goals in the Body Functions domain of the International Classification of Functioning (joint mobility, muscle tone, voluntary movement, pain, intellectual functions) and Activities and Participation domains (fine hand use, walking, moving around, interpersonal interactions and family relationships.

The Intensive correction course includes up to four hours of daily training. The treatment program is tailored individually according to the patient's condition and incorporates some of the following component according to individual indications and contraindications: Physical therapy, Occupational therapy, Full body massage, Spinal manipulative therapy, Joint mobilization techniques, Paraffin and wax applications, Reflexotherapy, Strength training, Computer game therapy, Suit therapy, Vibration therapy, Treadmill training, Group session of "rhythmic gymnastics". The influence of one technique complements and potentiates other rehabilitation components.

The aim of the study is to evaluate effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a randomized controlled trial.

A single-blinded randomized controlled trial with two groups will be conducted. The experimental group will undergo treatment course according to INRS, control group will continue receive usual home activity and care while staying on the waiting list. To avoid possible information leak about patient group allocation, the study should be performed in two independent centers: Evaluation center and Treatment center. Assessments will be conducted three times: at the baseline, in 3 weeks, and 7 weeks after the baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerebral Palsy bilateral spastic forms,
  • Age 4-12 years,
  • Gross Motor Function Classification System - Levels I-IV,
  • Manual Ability Classification System - Levels I-IV.

Exclusion criteria

  • Uncontrolled epileptic syndrome,
  • Severe intellectual disability,
  • Uncooperative behavior,
  • Surgery during ongoing year.

Treatment and study plan

Intensive Neurophysiological Rehabilitation System

Procedure

Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.

Activity and care as usual

Procedure

Control group continues usual activity and care while staying in the waiting list.

Primary outcomes

  1. Change in Gross Motor Function Measure score (GMFM-66)

    Time frame: Baseline, 3-week, and 7-week follow-up

    The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. The GMFM-66 version contains 66 items that span the spectrum from activities as lying and rolling up to walking, running, and jumping skills.

Secondary outcomes

  1. Change in Manual dexterity

    Time frame: Baseline, 3-week, and 7-week follow-up

    Manual dexterity is evaluated using Box and Blocks test. The score is the number of blocks carried by hand from one to another compartment in one minute.

  2. Change in Daily functioning- Self-Care

    Time frame: Baseline, 3-week, and 7-week follow-up

    Eating, grooming, dressing, bathing, and toileting skills are evaluated using Pediatric Evaluation of Disability Inventory (PEDI) Self-care questionnaire that includes 73 items, scales score is calculated.

  3. Change in Daily functioning- Mobility

    Time frame: Baseline, 3-week, and 7-week follow-up

    Transfers, indoor, and outdoor mobility skills are evaluated with Pediatric Evaluation of Disability Inventory (PEDI) mobility questionnaire that includes 59 items, scales score is calculated.

  4. Change in Jebsen-Taylor hand function score

    Time frame: Baseline, 3-week, and 7-week follow-up

    Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.

  5. Change in ABILHAND-Kids score

    Time frame: Baseline, 3-week, and 7-week follow-up

    The scale measures a person's ability to manage daily activities that require the use of the upper limbs. The parent is asked to fill in the questionnaire by estimating their child's performance of 21 manual activities on a 3-level scale (impossible, difficult, easy).

  6. Change in passive range of ankle dorsiflexion

    Time frame: Baseline, 3-week, and 7-week follow-up

    Range of motion is measured with a hand-held goniometer.

Sponsors and collaborators

Lead sponsor

International Clinic of Rehabilitation, Ukraine

Other

Collaborators

  • Elita Rehabilitation Center
  • I.Horbachevsky Ternopil National Medical University
  • Rainbow Kids e.V.

Registry information

Official study title

Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial

Acronym: IntReh4CP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2019
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.